BEUDAMED
    FDA Adverse Event Death Summary report: N

    PAGEWRITER TOUCH CARDIOGRAPH

    MDR report key: 2042199 · Received March 30, 2011

    Report

    Report Number
    1218950-2011-00831
    Event Type
    Death
    Date Received
    March 30, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    DPS
    PMA / PMN Number
    K020708
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVOLVED PT DIED, BUT THE HOSPITAL RISK MANAGER AND INVOLVED PHYSICIAN HAVE STATED THAT THE DEVICE BEHAVIOR WAS NOT A FACTOR IN THE PT OUTCOME. THIS COMPLAINT IS STILL BEING INVESTIGATED. A F/U REPORT WILL BE SUBMITTED AFTER PHILLIPS OBTAINS MORE INFO ABOUT THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN ECG WAS DONE ON A PT WHILE THE DEVICE WAS IN A SIMULATION MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAGEWRITER TOUCH CARDIOGRAPH DPS PHILIPS HEALTHCARE 860315

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR